Obesity Segment - Deal Opportunity?

All eyes are also on potential deal-making action in the obesity segment, where players like Eli Lilly and Company have indicated an intent to launch their weight loss therapy next year subject to regulatory approval and the supply situation.(Also see "Lilly CEO: Affordable Generics And IP Support 'Not Incompatible Ideas'" - Scrip, 1 March, 2024.)

To a question from Scrip on whether there have been early partnering discussions with Lilly for tirzepatide, MV Ramana, CEO – branded markets (India and emerging markets), Dr Reddy’s said: “There are several conversations with many multinational companies - I wouldn't be able to comment on something that is specific to a particular company”.

Peers like Cipla Limited have also indicated an intent to “present its credentials” as a potential strong partner should the US firm look at partnering options in India for tirzepatide.

India has been part of global studies for the glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist, data from the Clinical Trial Registry of India indicates. (Also see "Cipla Points To Large GLP-1 India Opportunity Amid Speculation On Lilly Deal" - Scrip, 29 January, 2024.)

Earlier this year, a subject expert committee (SEC) that advises the Indian drugs regulator gave the go ahead for import and marketing of tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5mg/0.5 ml and 15mg/.5 ml solution for injection (single dose vial) subject to certain conditions.

Lilly is required to conduct Phase-IV clinical trials and accordingly submit the trial protocol to India’s Central Drugs Standard Control Organization within three months from the date of approval for further review by the committee. “Further, the firm should fulfil the requirement of CMC data along with comparative data with that of already approved pre-filled pen,” the SEC (endocrinology and metabolism), added.

Tirzepatide was approved by the US FDA as Mounjaro for Type 2 diabetes in May 2022 and as Zepbound for obesity in November 2023.

Deals In Bag, Dr Reddy’s Sharpens Top 5 Targeted Home Run

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